After cranking up as much pressure as the industry could muster over the last year, lawmakers have been queuing up new laws aimed at speeding the FDA's review of drugs while gaining fresh pledges from regulators on flexibility and swifter decision-making. But a new study published in The New England Journal of Medicine concludes that an objective look at the data scuttles the whole notion that regulators in the U.S. are too slow when it comes to saying yes to a new therapy.
Investigators looked at every approval handed out for a new chemical entity between 2001 and 2010. They found that FDA regulators were on average 15% faster than either the EMA or Health Canada. Of the 225 drug applications studied, the average review time hit 322 days at the FDA. And the U.S. agency was the first to approve two of every three new drugs filed with both the FDA and the EMA.
"This allows us to focus on the important question of whether there are real barriers to drug innovation in the U.S.," Kathleen Stratton of the Pew Charitable Trusts told the AP. "But it's clear from this study that the speed at which the FDA reviews drug applications is not one of them." Pew, a noted advocate for public safety, funded the study undertaken by investigators at Yale and the Mayo Clinic.
It's unlikely that many executives in the biopharma industry would agree with that remark. Negotiations over the new PDUFA law includes pledges of speedier reviews and more predictable responses. That came after a long and intense campaign in which industry leaders moaned about the risky and enormously expensive drug development process. And some might argue that just because U.S. regulators are faster than colleagues in Europe and Canada, that doesn't make them as fast as they should be.
One other point: The review was limited to approved drugs, excluding the time involved for drugs that were ultimately red-flagged by the agency.
- here's the AP report